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Published on: May 19, 2023
Immunogenicity of FDA DTP versus WHO DTP
M Khalil1, Y Al-Mazrou, M Al-Howasi
1STAT Advisory Medical Center for Research Development, Cairo, Egypt, and Ministry of Health, Riyadh, Saudi Arabia.
Insights
Saudi infants showed higher tetanus and diphtheria antibody levels with the Federal Drug Administration (FDA) Diphtheria-Tetanus-Pertussis (DTP) vaccine compared to the World Health Organization (WHO) DTP vaccine. Both DTP formulas demonstrated good immunogenicity.
Area of Science:
- Pediatrics
- Immunology
- Vaccinology
Background:
- Investigating the immunogenicity of Diphtheria-Tetanus-Pertussis (DTP) vaccines in infants.
- Comparing World Health Organization (WHO) DTP and Federal Drug Administration (FDA) DTP formulations.
- Assessing vaccine response in six-week-old Saudi infants.
Purpose of the Study:
- To evaluate and compare the immunogenicity of three doses of WHO DTP and FDA DTP formulas in Saudi infants.
- To analyze antibody levels for diphtheria, pertussis, and tetanus after vaccination.
- To identify potential interactions between DTP vaccines and Haemophilus influenzae type b (HbOC) vaccine.
Main Methods:
- A randomized trial involving six-week-old infants receiving three doses of vaccines.
- Groups received either WHO DTP or FDA DTP, combined with HbOC, or a control group.
- Antibody levels (PRP, tetanus, diphtheria, pertussis) were measured post-vaccination.
Main Results:
- No significant difference in anti-PRP antibody levels between FDA DTP and WHO DTP groups.
- Significantly higher anti-tetanus and anti-diphtheria antibody levels in the FDA DTP group compared to the WHO DTP group.
- No adverse interactions observed between DTP vaccines and other vaccines after the third dose.
Conclusions:
- The FDA DTP formula demonstrates superior antigenicity for diphtheria and tetanus compared to the WHO DTP formula, despite lower antigen concentration.
- Both DTP formulations are immunogenic in Saudi infants.
- Re-evaluation of potency assay methods for DTP vaccines is recommended.
Background:
The aim of this report was to study the immunogenicity of three doses of DTP in six-week-old Saudi infants when given either as World Health Organization (WHO) DTP or Federal Drug Administration (FDA) DTP formula.
Methods:
As part of the Haemophilus influenzae type b immunization research protocol, six-week-old infants were randomized into three groups to receive three doses of HbOC and WHO DTP formula, HbOC and FDA DTP formula, or in a control group to receive the usual vaccines without HbOC, at six weeks, three months and five months. Antibody levels for PRP, tetanus, diphtheria and pertussis were measured after the third dose. The results of diphtheria, pertussis and tetanus are presented in this paper.
Results:
After three doses, no difference was found between anti-PRP when given with either FDA DTP or WHO DTP formula. Also anti-tetanus and anti-diphtheria antibodies were significantly higher in the group vaccinated with HbOC and FDA DTP formula, compared to children vaccinated with WHO DTP formula. No negative interactions with other vaccines were observed after the third dose. Conclusion. Although diphtheria and tetanus antigens in the FDA formula are half the concentration in the WHO formula, they are more antigenic. There is a need for methods of potency assay to be re-evaluated.
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